Is it a medical device?



Dear all,

We are creating two medical devices:

1. A wearable device that is meant for skin cancer patients. The device can tell exposure to UV. If the device indicates "high exposure" the patients must limit their exposure to UV in order to manage the symptoms of skin irritation or burn. Do you think this would be a medical device. If yes, why?

2. A biofeedback based wearable device that can be used by patients who have lost bladder control. The device will give an alarm to the patients to indicate that their bladder is full and they must go pee. This device prevents embarrassment. Would this be a medical device and why?

I referred to medical device definition on the FDA website and could not tell for sure. Your feedback will be greatly appreciated.

Thanks so much,
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My take is that US FDA applies its medical device definition expansively, excluding only products that are already regulated by another agency, or for which there is a clear historical precedent of non-regulation, or for which the politics are too hot, or for which the marketer makes a consistent and specific claim in all of its marketing communications that the product is not intended to be used for any purpose that would be consistent with it being a medical device.

I doubt if any of those exclusions are available to you. Your descriptions of the products here even both use the word "patient".


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i agree with miregmgr, both devices seem to meet the definition.
For biofeedback devices there is actually a classification 882.5050 and product code HCC
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